LYMEPOLICYWONK: Dr. Fallon’s Suggestions for Future Guidelines.
A recent article by Dr. Fallon and colleagues reviews the findings of the four clinical trials and accurately lays out the state of the science in chronic Lyme research. This is important because future research needs and policy decisions are determined by the state of the science. If there is definitive science that tells us whether treatment for chronic Lyme works, there is no need for additional science and guidelines may justifiably take a hard line on treatment options. Otherwise, we are dealing with science in the making, more studies are needed, and treatment guidelines should be more flexible.
One of the most frustrating things to me in Lyme disease is the way the IDSA commonly overstates the state of science, saying that the science on chronic Lyme disease is an open and shut case—that we don’t need any further research, that “definitive” studies have proven that treatment for Lyme disease is not effective, period, end of story. Overstating the science like this has devastating consequences for patients because it closes the doors on future research and leaves patients without treatment options.
Scientists usually are careful not to overstate or exaggerate the state of the science. This issue has risen to the level of an ethical principle with some scientific organizations. For example, the American Chemical Society states: “Public comments on scientific matters should be made with care and accuracy, without unsubstantiated, exaggerated, or premature statements.” (Moghissi et al. 2010). But in Lyme disease, the difference between the findings of the study (which reflect the science) and the conclusions (which include opinion) are often miles apart, reflecting strong viewpoints and controversy.
Dr. Fallon has done a real service by going through the four studies one-by-one and describing the state of the science. And looking at the NIH trials, we must recognize that some studies have shown improvement while others have not. These conflicting results reflect the emerging state of the science. He says we can’t assume that repeated antibiotic treatment of Lyme disease is ineffective; nor can we assume that it is robustly effective. We, can, however, assume that approximately 60% of those with fatigue improve with repeated treatment. We know this because this finding was confirmed in both the Krupp study and the Fallon study.
Finally, he notes that in translating the findings of the NIH trials to recommendations, we need to recognize that whether the benefits of treatment outweigh the risks associated with treatment depends on the individual circumstances of the patient. He suggests guideline text developers consider this type of a recommendation regarding the use of IV ceftriaxone (Rocephin):
IV ceftriaxone therapy is moderately efficacious for patients with chronic (>6 months) subjective fatigue after recommended antibiotic treatment regimens, but the risk associated with IV antibiotic therapy requires careful discussion with the patient of the cost benefit ratio. Sustained improvement from IV ceftriaxone therapy for other PTLDS symptoms such as physical dysfunction and pain is uncertain, with positive results suggested by one study but not by other studies.
This is essentially a recognition that when science is uncertain and the risk/benefit analysis involves trade-offs or close calls, clinical judgment and patient values matter. Sounds like the most often cited definition of evidence-based medicine by Dr. Sackett: “Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values.”
This blog concludes a three-part blog series on Dr. Fallon’s article. The previous two posts cover problems with small sample sizes and heterogeneity (differences) in sample populations.
References:
Fallon BA, Petkova E, Keilp J, Britton C. A reappraisal of the U.S. clinical trials of Post-Treatment Lyme Disease Syndrome. Open Neurology Journal. 2012;6(Supp. 1-M2):79-87. Available at http://benthamscience.com/open/toneuj/articles/V006/SI0078TONEUJ/79TONEUJ.pdf
Klempner M, Hu L, Evans J, Schmid C, Johnson G, Trevino R, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. The New England Journal of Medicine. 2001 Jul 12;345(2):85-92.
Krupp LB, Hyman LG, Grimson R, Coyle PK, Melville P, Ahnn S, et al. Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial. Neurology. 2003 Jun 24;60(12):1923-30.
Fallon BA. Lyme borreliosis: Neuropsychiatric aspects and neuropathology. Psychiatric Annals. 2006;36(2):120-28.
Sackett D et al. Evidence-Based Medicine: How to Practice and Teach EBM (2000)
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at lbjohnson@lymedisease.org.
Dr. Fallon’s research is important in so many ways, particularly because it raises new questions for researchers. For example, would other antibiotics or mixtures of antibiotics be as effective or more effective than ceftriaxone over the long term? If so, which ones?
Thank you for posting these studies by Brian Fallon.
The James Lind Alliance ( funded by the National Institute for Health Research) and working with UK charity Lyme Disease Action has reviewed the published research to identify areas of uncertainties. This will be voted on to priorities the top 10 with a view to attracting further research on those priorities.
Although this is a UK project it must be relevant Internationally.
It makes for interesting reading http://www.lymediseaseaction.org.uk/ with 39 documented uncertainties and others currently being researched, even the few questions found not to be uncertainties are not always recognised by our treating physicians.
In correspondence from the Dept of Health, Earl Howe, 12.12.2011 via my MP Anne Milton .The Dept of Health says ‘The Department is working with Lyme Disease Action (LDA) and I am aware that you as Health minister, have met with LDA representatives. We are supporting its initiative with the James Lind Alliance and await the findings of their review.’
Now that these findings do not support Dept of Health’s current stance on Lyme Disease will we see changes?
Yo vivo en Miami, ya no se que hacer pues desde 2009, un w Blot resulto positivo (High) de tres bandas 39, 23 y 41, a pesar que el primer dr infectologo me dijo “que no tenia Lyme” , despues ordeno 21 dias de Rosephin. He consultado 4 infectologos mas en estos 3 anos, que siguen diciendo que aqui no hay Lyme, que eso es en los eestados donde hay VENADOS , o que necesitare tener cinco BANDAS POSITIVAS .
En estos 3 anos he recibido ayuda de un dr en reumatologia que me ordeno un test en 2011 que resulto positivo, la banda 23, tambien.
En 2012 otro test volvio a ser positivo, la banda 66.
Otro Dr en Infecciiones,2011, me dijo que ya con 21 dias del antibiotico, fui curada.que me olvide de Lyme o me volvere loca. Mis sintomas son comprobados por pruebas de imagen, artritis, dificultades neurologicas, digestivas,cardiacas,sistema inmunologico deficiente, fatiga extrema y ademas todo esto me ha creado una gran depresion, que he tenido que manejar., ademas de muchos otros sintomas de Lyme.
Hace unos dias volvi a un nuevo infectologo y estaba tan desactualizado que me pregunto que” Donde estaba el Venado…que aqui no hay esas tipos de garrapatas.!!
No se que hacer ya, estoy muy cansada, mi medico primario me dice que quizas sean otras enfermedades y no Lyme….parece que como tengo 69 anos , piensan que son achaques por la edad y no estan tomando en cuenta la infeccion por borrelia.
Gracias a Uds, me he informado mucho y no me explico como esto puede suceder.
Necesito que por parte de Uds,alguna autoridad en la materia, se comuniquen con los hispanos, a traves de los medios de comunicacion y hablen sobre esta dolorosa y devastadora enfermedad, porque no se conoce y la gente no sabe que estan padeciendola quizas, confundiendose por parte de los medicos con otras.
Muchos estan sin diagnostico y sin un tratamiento correcto, segun mi experiencia.
He escrito cartas y emails a periodistas,tambien a organizaciones Lyme y no recibo ninguna a ayuda . Por favor hay que hacer algo urgentemente.
Muchas bendiciones y un saludo.
The entire issue of Rocephin NOT killing lyme (leaving multiplying cysts behind total failure) was solved years ago, by the Brorson study/Oslo Norway. FLAGYL or TIGECYCLINE R the only 2meds, under scope viewing, that kill the reproductive cyst common to all spirochetes (lyme). Rocephin at best is helping the unidentified co-infections of lyme. needs to be addressed that RED MEAT ALLERGY / MILK related same allergy, IS WHAT IS CAUSING ALL THE LYME SYMPTOMS. google red meat allergy tick bite. (I am one with, also lyme x several decades, BINGO.)
I saw Dr. Fallon’s study back in 2000. My daughter had just been diagnosed as Autistic after having Lyme Disease. Armed with the study in hand, I showed it to physician after physician. Not one of them believed that Lyme Disease could cause Autistic behavior. I gave up and finally contacted Dr. Fallon. He recommended seeing Dr. Charles Ray Jones. Forward 13 years…..My daughter is now 16, a straight A student, has a wonderful social life and is healthy and happy. Thanks to Charles Ray Jones and Dr. Fallon, my daughter survived Lyme Disease!!! I will forever cherish them in my heart!